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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
26.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

15 mg/kg bw/day × (1/0.38 m3/kg bw) × (6.7m3/10m3) × (100% rat oral absorption/100% human inhalation absorption)

AF for dose response relationship:
1
Justification:
Clear NOEL obtained in oral repeated dose study
AF for differences in duration of exposure:
6
Justification:
Default-subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scalling is required for inhalation
AF for other interspecies differences:
2.5
Justification:
default- remaining differences
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.112 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
26.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

15 mg/kg bw/day × (1/0.38 m3/kg bw) × (6.7m3/10m3) × (100% oral absorption/100% inhalation absorption)

AF for dose response relationship:
1
Justification:
Clear NOEL obtained in oral repeated dose study
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scalling is required for inhalation
AF for other interspecies differences:
2.5
Justification:
default- remaining differences
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining differences

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.05 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

15 mg/kg bw/day × (100% oral absorption/100% dermal absorption)

AF for dose response relationship:
1
Justification:
Clear NOEL obtained in the oral repeated dose study
AF for differences in duration of exposure:
6
Justification:
default - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default - rat to human
AF for other interspecies differences:
2.5
Justification:
default - remaining differences
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

15 mg/kg bw/day × (100% oral absorption/100% dermal absorption)

AF for dose response relationship:
1
Justification:
Clear NOEL obtained in oral repeated dose study
AF for interspecies differences (allometric scaling):
4
Justification:
default - rat to human
AF for other interspecies differences:
2.5
Justification:
default - remaining differences
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining differences

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The substance was tested via the oral route in an acute toxicity and a 28 -day repeated dose study. In the acute oral toxicity study the LD50 is between 300 - 2000 mg/kg and therefore the substance is classified for acute oral toxicity. In the 28 -day study the NOEL was 15 mg/kg bw/day. This was used as the starting point for long- and short- term systemic DNELs derivation and is considered protective enough for workers.

The substance is a skin corrosive (category 1C) and therefore local effects are expected, but no DNEL/DMEL can be derived.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.09 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
13 mg/m³
Explanation for the modification of the dose descriptor starting point:

15 mg/kg bw/day × (1/1.15 m3/kg bw) × (100% oral absorption/100% inhalation absorption)

AF for dose response relationship:
1
Justification:
Clear NOEL obtained in oral repeated dose study
AF for differences in duration of exposure:
6
Justification:
default - subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scalling is required for inhalation
AF for other interspecies differences:
2.5
Justification:
default - remaining differences
AF for intraspecies differences:
10
Justification:
default for general public
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.52 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
13 mg/m³
Explanation for the modification of the dose descriptor starting point:

15 mg/kg bw/day × (1/1.15 m3/kg bw) × (100% oral absorption/100% inhalation absorption)

AF for dose response relationship:
1
Justification:
Clear NOEL obtained in oral repeated dose study
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scalling is required for inhalation
AF for other interspecies differences:
2.5
Justification:
default - remaining differences
AF for intraspecies differences:
10
Justification:
default for the general public
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.03 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

15 mg/kg bw/day × (100% oral absorption/100% dermal absorption)

AF for dose response relationship:
1
Justification:
Clear NOEL obtained in the oral repeated dose study
AF for differences in duration of exposure:
6
Justification:
default - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default - rat to human
AF for other interspecies differences:
2.5
Justification:
default - remaining differences
AF for intraspecies differences:
10
Justification:
default for the general public
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.15 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

15 mg/kg bw/day × (100% oral absorption/100% dermal absorption)

AF for dose response relationship:
1
Justification:
Clear NOEL obtained in oral repeated dose study
AF for interspecies differences (allometric scaling):
4
Justification:
default - rat to human
AF for other interspecies differences:
2.5
Justification:
default - remaining differences
AF for intraspecies differences:
10
Justification:
default for general public
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.03 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOEL oral = 15 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Clear NOEL obtained in the oral repeated dose study
AF for differences in duration of exposure:
6
Justification:
default - subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default - rat to human
AF for other interspecies differences:
2.5
Justification:
default - remaining differences
AF for intraspecies differences:
10
Justification:
default for the general public
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.15 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOEL oral = 15 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Clear NOEL obtained in repeated dose study
AF for interspecies differences (allometric scaling):
4
Justification:
default - rat to human
AF for other interspecies differences:
2.5
Justification:
default -remaining differences
AF for intraspecies differences:
10
Justification:
default for general public
AF for the quality of the whole database:
1
Justification:
database complete for the tonnage band
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

The substance was tested via the oral route in an acute toxicity and a 28 -day repeated dose study. In the acute oral toxicity study the LD50 is between 300 - 2000 mg/kg and therefore the substance is classified for acute oral toxicity. In the 28 -day study the NOEL was 15 mg/kg bw/day. This was used as the starting point for long- and short- term systemic DNELs derivation and is considered protective enough for the general public.

The substance is a skin corrosive (category 1C) and therefore local effects are expected, but no DNEL/DMEL can be derived.